MAUDE Adverse Event Report: NULL PORTEX; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2021

Event Type  malfunction  

Event Description

It was reported that the customer reported the tube came apart during use.

Manufacturer Narrative

No device was returned for investigation.Investigation of this complaint was done based on photos provided by customer.On the photos there is shown that uniperc connector was disconnected from tracheostomy tube.Complaint history was checked and no trend of confirmed customer complaints was identified.This issue is considered to be isolated incident and with unknown root cause.Without the sample we are unable to determine the root cause.

• Brand Name: PORTEX
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section G): NULL
• MDR Report Key: 13196699
• MDR Text Key: 283833820
• Report Number: 3012307300-2022-00325
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1